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Sargramostim for Myeloid Dendritic Cell Deficiency

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dendritic Cell Deficiency

Intervention: Sargramostim (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Karl L Womer, MD, Principal Investigator, Affiliation: Johns Hopkins University

Summary

Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.

Clinical Details

Official title: Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age >18 years < 80 years with diagnosis of end stage renal disease and currently

undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units Exclusion Criteria:

- Age<18or>80years

- History of non-adherence to prescribed HD treatment

- Active drug or heavy alcohol use (defined as > 4 drinks/day)

- Pregnancy or breast feeding

- Active infection (bacterial or viral) or clinically significant infections within the

past three months (e. g. those requiring hospitalization, or as judged by the PI)

- Active malignancy (with the exception of excised non-metastatic basal cell carcinoma

or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)

- Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)

- History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) •

History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)

- Known hypersensitivity to yeast-derived products

- Hemoglobin < 10 g/dL and hematocrit < 30%.

- Abnormal white blood cell (WBC) count at baseline (< 3 or > 12 x 10 cells/mm )

- Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications

(tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)

- Treatment with lithium within 4 weeks of study

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21205, United States
Additional Information

Starting date: May 2013
Last updated: May 20, 2015

Page last updated: August 23, 2015

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